Kornimate/medical-research-clean huggingface dataset:
mle4901 vs. placebo for the treatment of pcos

Conditions: Polycystic Ovary Syndrome (PCOS)

Summary: this is a phase 2b double-blind, randomized, parallel-group, placebo-controlled study of mle4901 versus placebo in women with pcos.

following a screening/wash-out period of up to 12 weeks, an 8-week lead-in period (starting with a progestin challenge) will be used to better characterize the study population. a treatment period of 28 weeks' duration will follow the lead-in period. then, an 8-week follow-up period (i.e., no study drug) will be used to assess the durability of effects of mle4901. the study duration will be approximately 48 weeks (11 months) per subject

Eligibility criteria:
inclusion criteria: 1. oligo-/amenorrhea 2. at least one of the following during screening: * clinical signs of hyperandrogenism, where clinical hyperandrogenism may include hirsutism (defined as excessive terminal hair that appears in a male pattern), acne, or androgenic alopecia * biochemical hyperandrogenism refers to an elevated serum androgen level (i.e., total, bioavailable or free testosterone level ≥uln) * polycystic ovarian morphology, defined as the presence of 12 or more follicles 2-9 mm in diameter and/or an increased ovarian volume \>10 ml (without a cyst or dominant follicle) in either ovary 3. body mass index (bmi) 22 to 45 kg/m2, inclusive 4. must be willing to avoid use of all hair removal procedures and products during study participation 5. must be willing to avoid all prescription treatments for acne and not increase the dose or frequency of their current non-prescription acne treatment regimen during study participation 6. must be willing to avoid the use of all hair growth procedures and products during study participation 7. permanently surgically sterilized (bilateral salpingectomy or tubal occlusion) \>2 years or male partner(s) has had a vasectomy \>2 years or must consent to use two permitted medically-acceptable methods of contraception throughout the study during any sexual intercourse with a male partner. permitted medically-acceptable methods of birth control for this study are defined as use of a male condom plus one of the following: spermicide, diaphragm with spermicide, or an intrauterine device that does not contain steroid hormones. exclusion criteria: 1. menopausal or peri-menopausal, defined for this study as fsh (follicle stimulating hormone ) \>10 iu/l 2. irregular vaginal/menstrual bleeding caused by conditions other than pcos (e.g., uterine polyps or submucosal uterine fibroids) 3. abnormal papanicolaou (pap) test during screening requiring follow-up sooner than 1 year after the test 4. uncontrolled hypo- or hyperthyroidism 5. post-hysterectomy or endometrial ablation 6. post-oophorectomy (unilateral or bilateral) or other ovarian surgery 7. medical history of type 1 or type 2 diabetes mellitus

Keywords: acne hirsutism menstrual irregularity alopecia
interest of repetitive transcranial magnetic stimulation (rtms) in the treatment of auditory hallucinations

Conditions: Schizophrenic Disorders

Summary: auditory hallucinations are common (present in 60-70% of cases) and extremely debilitating. behavioral disorders associated with them can have serious social repercussions. however, in 25% of cases the usual antipsychotic drug treatments are incompletely or totally ineffective. fifteen subjects will be included after collection and signed their informed consent. the rtms treatment is made of 4 sessions of 13 minutes spread over two days, at a frequency of 20 hz and an intensity of 80% of motor threshold at rest. these constants are used to stay below the risk of occurrence of seizures, the only serious side effects identified. furthermore the rtms treatment is almost painless: tension headaches are the main side effects and make amends with simple analgesics. rtms is devoid of neurocognitive effects. the left stimulation site will be established through a anatomofunctional imaging before treatment (between d-7 and d0). treatment efficacy will be evaluated daily during treatment (days 1 and 2) and during the first 2 weeks of starting treatment.


Eligibility criteria:
inclusion criteria: * patients with schizophrenic disorders aged from 18 to 60 years old * patients suffering from auditory hallucinations undergoing antipsychotic treatments * written signed consent exclusion criteria: * pregnancy or breastfeeding * counter-indication to mri or to rtms

Keywords: schizophrenia auditory hallucinations tms
a study of fluorescein sodium in people undergoing vulvectomy for extramammary paget's disease (empd)

Conditions: Extramammary Paget's Disease

Summary: the researchers are doing this study to see if giving people fluorescein sodium as an iv infusion before their vulvectomy for treating extramammary paget's disease (empd) can help surgeons with performing the procedure. the researchers will look at whether fluorescein sodium helps surgeons identify disease cells that should be removed. other purposes of this study include looking at the following: if there are any complications during or after vulvectomy involving the use of fluorescein sodium. if fluorescein sodium can reveal tissue that surgeons cannot operate on (unresectable tissue).


Eligibility criteria:
inclusion criteria: * age ≥18 years * noninvasive or microinvasive empd with a contiguous visible clinical lesion * newly diagnosed or recurrent lesion * scheduled to undergo wide local excision or vulvectomy not requiring resection of the clitoris, urethra, or anus and with the surgeon's judgment that primary closure is possible (v-y advancement flap closure is allowed) exclusion criteria: * history of allergic reaction to fluorescein sodium * multifocal, noncontiguous clinical lesion * current or previous invasive empd * history of invasive vulvar, vaginal, or anal cancer * lesion in which resection of the clitoris, urethra, and/or anus is deemed to be necessary * lesion in which a primary closure or v-y advancement flap is believed not to be possible and a larger myocutaneous flap is needed for closure of the defect * history of radiation therapy to the vulva and/or anus

Keywords: fluorescein mapping vulvectomy 25-002
effect of tibet rhodiola capsule on hypoxia and cardiovascular risk factors in patients with obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to evaluate the effect of tibet rhodiola capsule on hypoxia and the cardiovascular risk factors in patients with mild to moderate osa.


Eligibility criteria:
inclusion criteria: 1. age \>18 years, males or females; 2. hsat or psg testing within recent 3 months; 3. ahi 5-30 and lowest oxygen saturation\<85%; 4. refuse to accept cpap, mandibular orthosis device, surgery, or other medications to improve osa; 5. written informed consent. exclusion criteria: 1. history of cpap, mandibular orthosis device, surgery, or other medications to improve osa; 2. significant central sleep apnea; 3. histories of other sleep disorders: insomnia, chronic sleep deprivation, long-term use of sleeping pills or sedatives, restless legs syndrome; 4. histories of underlying heart disease (cardiomyopathy, myocarditis, pericarditis or severe valvular disease), cardiogenic shock and heart failure (nyha or killip class 3-4), persistent atrial or ventricular arrhythmias; 5. history of myocardial infarction, coronary revascularization, and a known degree of stenosis \> 75% of the coronary lesions; 6. histories of known serious liver dysfunction (alt or ast levels above 3 times the normal limit), renal insufficiency (gfr\<30ml/min), moderate and severe chronic obstructive pulmonary disease, and pulmonary arterial hypertension; 7. patients with malignant tumors, lymphoma and neuropsychiatric disorders; 8. patients with major surgery or trauma within 3 months, and active bleeding or cerebrovascular accident within 6 months; 9. history of anemia (hemoglobin\<90g/l) or thrombocytopenia (thrombocyte \<90×10\^9/l); 10. breastfeeding, pregnant, or potentially fertile women; 11. patients who have known to be allergic to tibet rhodiola capsule or its components or patients with serious adverse effect; 12. participation in other clinical trials in recent 3 months; 13. patients who cannot complete this trial or comply with the protocol.
bcc excision revisited

Conditions: Basal Cell Carcinoma; Eye Diseases; Eye Cancer

Summary: to readdress basal cell carcinoma (bcc) in the periocular region to prove histologically controlled surgical treatment efficacy and to identify high-risk characteristics.


Eligibility criteria:
inclusion criteria: * patient records were reviewed for the presence of bcc and surgical excision with frozen sections control of the wound margins in the periocular region, * conducted between 01.01.2009 and 31.12.2019. * periocular was defined as the area involving the medial and lateral canthus as well as the upper and lower eyelids. exclusion criteria: * bccs outside of this region were excluded from this analysis, * as well as incomplete records.
gemcitabine-carboplatin versus gemcitabine-oxaliplatin in cisplatin-unfit urothelial carcinoma

Conditions: Advanced Urothelial Carcinoma

Summary: cisplatin-based chemotherapy is the standard regimen for advanced urothelial carcinoma. but cisplatin-unfit patients account for up to 30-40% of patients in clinical practice. recently reported phase ii/iii trial of eortc 30986 comparing gemcitabine/carboplatin (gcb) with mcavi (methotrexate, carboplatin, vinblastine) suggested that gcb be the preferred regimen over mcavi based on the response rates, adverse events, and severe acute toxicities. but the grade 3 or worse toxicities associated with gcb are not infrequent and need more effective and more tolerable regimens. gemox has been reported to be effective and have very favorable toxicity profiles.


Eligibility criteria:
inclusion criteria: * cytologically of histologically confirmed urothelial carcinoma * locally advanced or metastatic disease * measurable disease according to recist v.1.1 * ecog ps 0-2 * cisplatin-unfit condition (any of the followings: nyha functional class 3, creatinine clearance 30-60 ml/min, and ecog ps=2) * adequate organ function * chemotherapy-naive exclusion criteria: * histology other than urothelial carcinoma, but squamous cell carcinoma or adenocarcinoma mixed with urothelial carcinoma are allowed * cns metastases * peripheral neuropathy grade 2 or worse * serious medical or surgical conditions

Keywords: cisplatin-unfit condition
pan-eu utilization, effectiveness and safety of ipilimumab administered in eap patients with advanced melanoma

Conditions: Melanoma

Summary: observational study to evaluate the effectiveness and safety of ipilimumab, administered during the european expanded access programme (eap) in pretreated patients with advanced (unresectable or metastatic) melanoma.

minimum age: 18 years old (at time of inclusion in the ca184-367- but 16 for the eap)

Eligibility criteria:
inclusion criteria: * patients have been enrolled in the eaps * patients still alive must provide informed consent if required by local regulations * deceased patients are eligible per local regulations, their legal representatives must provide informed consent if required by local regulations exclusion criteria: * there are no specific exclusion criteria in this observational study other than the exclusion criteria of the eap
pd-l1 targeting nanobody probe for pet imaging of solid tumor

Conditions: Lung Cancer; Melanoma; PD-L1; PET/CT

Summary: the objective of this study is to construct a noninvasive approach using 68ga-thp-apn09 pet/ct to detect the pd-l1 expression of tumor lesion in patients with lung cancer, melanoma and other solid tumor to identify patients benefiting from anti-pd-(l)1 treatment.


Eligibility criteria:
inclusion criteria: 1. aged 18-75, male and female, with ecog score of 0 or 1; 2. subjects with head and neck tumors, lung cancer, esophageal cancer, breast cancer, ovarian cancer, cholangiocarcinoma, colorectal cancer, gastric cancer, pancreatic cancer, melanoma, bone or soft tissue sarcoma, solid tumors or suspected tumor subjects who intend to undergo pathological tissue biopsy or receive tumor surgical treatment in the near future (within 2 months); 3. the expected survival was more than 26 weeks; 4. blood routine test, liver and kidney function meet the following standards: blood routine: wbc \>= 4.0 x 10\^9/l or neutrophil \>= 1.5 x 10\^9/:, plt \>= 100 x 10\^9 / l, hb \>= 90g / l; pt or aptt \<= 1.5 upper limit of normal value; liver and kidney function: total bilirubin \<= 1.5 x ult (upper limit of normal value), alt / ast \<= 2.5 upper limit of normal value or \<= 5 x ult (subject with liver metastasis), alp \<= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, alp \<= 4.5 upper limit of normal value); bun \<= 1.5 x ult, scr \<= 1.5 x ult; 5. according to recist1.1, there was at least one measurable target lesion; 6. women must take effective contraceptive measures during the study period and within 6 months after the end of the study; men should agree to use contraceptive measures during the study period and within 6 months after the end of the study period; 7. understand and sign informed consent voluntarily with good compliance. exclusion criteria: 1. the function of liver and kidney was seriously abnormal; 2. preparation for pregnant, pregnant and lactating women; 3. inability to lie flat for half an hour; 4. suffering from claustrophobia or other mental disorders; 5) other researchers considered it unsuitable to participate in the trial.
enteric-coated mycophenolate sodium versus azathioprine for the extra-renal lupus manifestations

Conditions: Systemic Lupus Erythematosus

Summary: azathioprine is still considered the treatment of choice for the non-renal manifestations of systemic lupus erythematosus (sle) with an estimated efficacy of 45%.recently, several studies have demonstrated the efficacy of mycophenolate mofetil/enteric-coated mycophenolate sodium in those cases, but so far, no controlled, randomized comparative study between the two drugs has been conducted. the aim is to perform a randomized, controlled, phase iii/iv study comparing enteric-coated mycophenolate (ecms) with azathioprine for induction and maintenance therapy of the non-renal manifestations of sle. methods: patients with non-renal sle flares (sledai≥6 and/or bilag o 2b refractory to full doses of hydroxychloroquine and prednisolone (≥10 mg/d) or with relapsing flares will be included. patients will be stratified according the flare severity (moderate (sledai\<12)-severe (sledai≥12)) and randomized (1:1) into two groups of treatment, emcs (2gr/d) or aza (2-2.5mg/kg/d) according to tmpt levels for 6 months. dose will be progressively tapered based on clinical response up to completing a year of treatment. the main aim is the percentage of complete remission achieved ((sledai \<4 and/or absence of any bilag a o b) at week 12 and 24 for moderate and severe flares, respectively. secondary objectives include evaluating the reduction in the steroid requirement, number of flares post-treatment, effect on the biological parameters, and impact on quality of life, damage and drug safety. to detect a 20% difference between the two drugs with a 80% statistical power (0.05 alpha error), considering a follow up loss of 20%, a total of 240 patients is required.


Eligibility criteria:
inclusion criteria: * age\>18 years * fulfill at least 4 of the 11 criteria for the acr classification * any extra-renal flare with an sledai\>6 and/or one bilag a or 2 b * oral corticosteroids\>10 mg/day and hcq \> 400 mg/day for at least 30 days prior to inclusion exclusion criteria: * presence of active renal disease * previous intolerance or hypersensibility to any of the active components * active infection * unmeasurable levels of tmpt * pregnancy * presence of a severe flare that requires other immunosuppressive treatment for its control * any psychiatric or social condition that did not ensure the patient´s follow-up and patient´s collaboration * previous treatment with ec-mps or azathioprine in the last 2 months * previous treatment with biological therapy in the last 3 months for anti-tnf therapy or in the last year for anti-cd20 therapy * alt or gpt \>120 ui/ml non-lupus related in the last 30 days * leucopenia \<1000x10e6 non-lupus related in the last 30 days * symptoms related to other medical conditions non-lupus related such as antiphospholipid syndrome.

Keywords: sle non-renal manifestations
continuous positive airway pressure (cpap) pediatric patients with subglottic stenosis who undergo balloon dilatation

Conditions: Airway Complication of Anesthesia; Congenital Subglottic Stenosis

Summary: nasal continuous positive airway pressure (cpap) acts as a 'pressure' bridge between spontaneous breathing and controlled mechanical ventilation. as a result, there is an increasing trend in the prophylactic use of nasal cpap in pediatric patients following high-risk airway procedures to reduce postoperative airway complications. still, there is no study published on the prophylactic use of balloon dilatation in children with tracheal stenosis.the study hypothesizes that implementing postoperative prophylactic cpap in pediatric cases with subglottic stenosis undergoing balloon dilation may shorten recovery time and minimize airway complications.

acquired pediatric subglottic stenosis is reported to have a prevalence of 1-2% . this rate reaches 8.3% in different case series. acquired pediatric subglottic stenosis is commonly attributed to prolonged intubation, whereas the etiology also involves a history of traumatic or difficult airway. balloon dilation laryngoplasty is an efficient and safe technique for treating primary and secondary acquired laryngotracheal stenosis. it is successfully applied in these children. airway surgery typically necessitates a deeper level of anesthesia to control airway reflexes and manage the fluctuations in hemodynamic parameters, which are characteristic of this surgery. nevertheless, general anesthesia must be applied several times to patients due to the need for multiple balloon dilatations. at the same time, the procedure also necessitates coping with postoperative complications that may arise. because alveolar collapse, which is related to general anesthesia, impairs gas exchange by creating a shunt effect, potentially increasing perioperative hypoxemic episodes, which in turn increases the risk for postoperative pulmonary complications. a recent retrospective analysis found that 40.6% of children who underwent balloon dilation experienced desaturation. additionally, tracheotomy was required in 15.6% of cases, with an equal percentage needing tracheal intubation. prophylactic cpap in pediatric cases has been shown to improve oxygenation by reducing the alveolar-arterial oxygen difference after pediatric laparoscopic surgery. however, it has been proven that cpap applied after pediatric cardiac surgery has favorable effects on peak expiratory flow.

Eligibility criteria:
inclusion criteria: * asa 2-3 * acquired or congenital subglottic stenosis exclusion criteria: * congenital or acquired diseases of the primary lung or choanal atresia * younger than 38 gestational weeks * intubated patients * congenital cardiac defects

Keywords: pediatric airway subglottic stenosis apne cpap
hospitalizations during pandemia in the italian coronary care unit network

Conditions: Management and Epidemiology of Patients Admitted in ICU

Summary: multicentre, national, observational, retrospective and prospective study. the blitz-covid19 study aims at describing the epidemiology of admissions to italian cardiology intensive care units in the covid-19 infection pandemia, the main aspects of the clinical management of inpatients, their short-term outcome, the absorption of resources related to their admission.

the blitz-covid19 study, aims at describing the epidemiology of admissions to italian cardiology intensive care units . the study is observational, multicentre, national and involves the collection of clinical data, both retrospectively and prospectively, using a web-based system. in conducting the study, no drugs are tested, nor are diagnostic tests or non-pharmacological therapies performed other than those that each participating cardiologist decides to perform following the rules of normal clinical practice. diagnostic procedures and pharmacological and non-pharmacological therapies habitually prescribed for cardiovascular pathologies, which are the object of hospitalization, and those used in the event of a covid-19 infection, will be recorded in the database.

Eligibility criteria:
inclusion criteria: - all patients aged ≥18 years admitted with any diagnosis to one of the participating icu exclusion criteria: - refuse to signe consent
calls: cml and ph+all low level mutation prevalence survey

Conditions: Chronic Phase Chronic Myelogenous Leukemia; Accelerated Phase Chronic Myelogenous Leukemia; Blastic Phase Chronic Myelogenous Leukemia; Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

Summary: a multicenter, prospective cohort study of the mutation status of patients with chronic myeloid leukemia (cml) and philadelphia chromosome-positive acute lymphoblastic leukemia (ph+ all) who are being treated with first or subsequent tyrosine kinase inhibitor (tki) therapy in the uk, ireland, or france.


Eligibility criteria:
inclusion criteria: * adult patients (age ≥ 18 years) with cml (in all phases of disease) or ph+ all with detectable bcr-abl levels who are being treated with a first or subsequent tki. * patients with cml must meet the warning or failure criteria as per the eln guidelines for first second and subsequent treatment line, including: * bcr-abl/abl is transcripts \> 10% at 3 months * bcr-abl/abl is transcripts \> 1% at 6 months * bcr-abl/abl is transcripts \> 0.1% at 12 months or later * patients with cml must not currently be in mmr (ie, have disease with bcr-abl1/abl1 transcripts \> 0.1% is). or * patients with ph+ all with any level of bcr-abl/abl is transcripts. patients with ph+ all should have bcr-abl1/abl1 transcript levels \> 0.1% and should not be currently enrolled in ukall14 but may have relapsed during or after participation in ukall14. * patients with an intermediate or high sokal score (\> 0.8) can be recruited into the study from 3 months after diagnosis, irrespective of bcr-abl1/abl1 transcript levels at 3 months. * patients with additional chromosomal abnormalities at diagnosis and patients with ap-cml may be recruited into the study, irrespective of bcr-abl1/abl1 transcript levels at 3 months and beyond provided bcr-abl1/abl1 transcript levels are \> 0.1% is. it is recommended that these patients have mutational analysis performed every 3 months irrespective of bcr-abl1/abl1 transcript levels until they reach mr3/mmr (bcr-abl1/abl1 \< 0.1% is). * any patients who have previously undergone testing for kd mutations, irrespective of kd mutational analysis test results. * patients who have the ability to understand the requirements of the study and provide written informed consent. exclusion criteria: patients without detectable bcr-abl and patients who have switched tki due to intolerance but who have met the criteria for optimal response (cp-cml, eln 2013 guidelines).

Keywords: chronic myeloid leukemia chronic phase accelerated phase blast phase philadelphia chromosome-positive acute lymphoblastic leukemia tyrosine kinase inhibitor